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Limber Prosthetics, Inc. — FDA Facility Profile

FEI 3030088168

Limber Prosthetics, Inc. is an FDA-registered facility (FEI 3030088168) located in San Diego, CA, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Mar 20, 2026: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 20, 2026Voluntary Action Indicated (VAI)GUDID Information required for unique device identification. (21 CFR 830.310(b))
Inadequate monitoring and control over outsourced processes (ISO 13485:2016 Clause 4.1.5)
QMS software not validated prior to use or changes (ISO 13485:2016 Clause 4.1.6)

Facility details

Company
Limber Prosthetics And Orthotics, Inc
Location
San Diego, CA (US)
Source
device

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.